DRAFT UGANDA STANDARD  
  DUS 2381  
First  Edition  
2022-mm-dd 
 
 
 Reference number  
DUS 2381 : 202 2 
© UNBS 202 2  
  
Reusable m enstrual cup  — Specification  
 
 
 
 DUS 2381: 2022 
ii © UNBS 2022 – All rights reserved  
 Compliance with this standard does not, of itself confer immunity from legal obligations  
A Uganda Standard does not purport to include all necessary provisions of a contract. Users are 
responsible for its correc t application  
© UNBS 2022  
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilised in any 
form or by any means, electronic or mechanical, including photocopying and microfilm, without prior written 
permiss ion from UNBS.  
Requests for permission to reproduce this document should be addressed to  
The Executive Director  
Uganda National Bureau of Standards  
P.O. Box 6329  
Kampala  
Uganda  
Tel: +256 41 7 333 2 50/1/2 
Fax: +256 41 4 286 123  
E-mail: info@unbs.go.ug  
Web: www.unbs.go.ug  
 
 DUS 2381 :2022 
© UNBS 202 2 – All rights reserved  iii 
 Foreword  
Uganda National Bureau of Standards (UNBS) is a parastatal under the Ministry of Trade , Industry and 
Cooperatives established under Cap 327 , of the Laws of Uganda , as amended .  UNBS is mandated to co -
ordinate the elaboration of standards and is  
(a) a member of International Organisation for Standardisation (ISO) ;  
(b) a contac t point for the WHO/FAO Codex Alimentarius Commission on Food Standards ; and  
(c) the National Enquiry Point on TBT  Agreement  of the World Trade Organisation (WTO).  
The work of preparing Uganda Standards is carried out through Technical Committees. A Technical  
Committee is established to deliberate on standards in a given field or area and consists of key stakeholders 
including government, academia, consumer groups, private sector and other interested parties.  
Draft Uganda Standards adopted by the Technical Co mmittee are widely circulated to stakeholders and the 
general public for comments. The committee reviews the comments before recommending the draft standards 
for approval and declaration as Uganda Standards by the National Standards Council.  
The committee responsible for this document is Technical Committee UNBS/TC 315, Textiles and related 
products.  
 DUS 2381: 2022 
iv © UNBS 2022 – All rights reserved  
 Introduction  
Many girls and women do not have access to appropriate menstrual health management (MHM) products, i.e., 
products that are effective, comfort able,  affordable and safe to use, leaving them to resort to products 
available, often of a poor quality. The lack of appropriate MHM products can have far -reaching implications for 
women and girls in the physical, social and mental wellbeing, as well as fo r the ir sexual reproductive health 
and rights. Women and girls’ capacity to manage their periods is affected by many factors, including taboos 
about the subject, limited access to affordable and hygienic MHM products and lack of proper disposal options 
of produ cts. This can have far -reaching implications for women and girls’ physical, social and mental 
wellbeing, as well as for their sexual reproductive health and rights.  
These MHM issues are often further exacerbated by insufficient access to safe and pri vate toilets, and lack of 
clean water and soap for personal hygiene. As a result, many women and girls have to manage their periods 
in ineffective, uncomfortable and unhygienic ways, contributing to them feeling shame and restricting them 
from reaching the ir full potential in social, school and work settings.  
The menstrual cup is not a new innovation. But in recent years, it has increasingly been introduced as a more 
sustainable way to improve the MHM of women and girls in low -income contexts. It is a bell -shape d cup, 
usually made of medical -grade silicone which is inserted in the vagina during menstruation to collect 
menstrual flow. A menstrual cup can be worn for up to 12 hours before emptying depending on one’s flow. 
Once the user becomes familiar with it s use , it is comfortable and unobtrusive and can be easily washed and 
stored, for up to ten years . 
There are both disposable and reusable menstrual cups.  
 DRAFT UGANDA STANDARD  DUS 2381 : 202 2 
 
© UNBS 2022 – All rig hts res erved  1 
 Reusable m enstrual cup — Specification  
1 Scope  
This Draft Uganda Standard specifies requir ements, sampling and test methods for reusable menstrual cups .  
2 Normative references  
The following documents are referred to in the text in such a way that some or all of their content constitutes 
requirements of this document. For dated references, onl y the edition cited applies. For undated references, 
the latest edition of the referenced document (including any amendments) applies.  
ISO 14 362-1, Textiles — Methods for determination of certain aromatic amines derived from azo colorants — 
Part 1: Detection of the use of certain azo colorants accessible with and with out extracting the fibres  
ISO 14 362-3, Textiles — Methods for determination of certain aromatic amines derived from azo colorants — 
Part 3: Detection of the use of certain azo colorants, which may release 4 -aminoazobenzene  
ISO 16373 -1, Textiles — Dyestuffs — Part 1: General principles of testing coloured textiles for dyestuff 
identification  
ISO 16373 -2, Textiles — Dyestuffs — Part 2: General method fo r the determination of extractable dyestuffs 
including allergenic and carcinogenic dyestuffs (method using pyridine -water)  
ISO 16373 -3, Textiles — Dyestuffs — Part 3: Method for determination of certain carcinogenic dyestuffs 
(method using triethylamine/methanol)  
US ISO 2859 -1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by 
acceptance quality limit (AQL) for lot -by-lot inspection  
US ISO 10993 -1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk 
management process  
US ISO 10993 -5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotox icity 
US ISO 10993 -10, Biological evaluation of medical devices — Part 10: Tests for skin sensitization  
3 Terms and definitions   
For the purposes of this document, the following t erms  and definitions apply.  
ISO and IEC mainta in terminological databases for use in standardization at the following addresses:  
— ISO Online browsing platform: available at http://www.iso.org/obp  
menstrual cup  
bell-shaped cup, usually made of medical -grade silicone which is inserted in the vagina du ring menstruation to 
collect menstrual flow  DUS  2381 : 202 2 
2 © UNBS 2022 – All rights reserved  
 4 Requirements  
4.1 General requirements  
4.1.1  Reusable menstrual cups shall be made out of surgical  rubber , thermoplastic elastomer  (TPE) or 
medical grade silicone.  
4.1.2 The materi als used for making reusable menstrual  cups shall be inert  to avoid reactions with materials 
they come in contact with. 
4.2 Speci fic requirements  
4.2.1  Dimensions  
4.2.1. 1 A typical shape of a menstrual cup is shown in Figure.1.  
 
Figure 1 — An illustration of a typic al menstrual cup  
4.2.1.2  When measured  with the aid of a micrometre screw gauge,  the menstrual cup shall compl y with 
the dimensions declared on the label subject to a tolerance of ± 2% 
4.2.1.3  The wall thickness shall be between 1.5 mm – 2.5 mm  when measured with the aid of a 
micrometre screw gauge.  
4.2.2  Capacity  
When filled with cle an w ater, a menstrual cup shal l comply  with the volume of flow declared on the label.  
4.2.3  Biocompatibility  
When tested in accordance with US  ISO10993 -1, ISO 10993 -5 and ISO 1 0993 -10, the reusable menstrua l 
cup shall be not be cytotoxic n or cause sensitization or muco sal irritation.  
4.2.4  Sterilization  
Reusable menstrual cup s shall be able to withstand the high temperatures of sterilization  subject to 121 0C for 
20 mins or 134 0C for 3 mins.  DUS  2381 : 202 2 
© UNBS 2022 – All rights reserved  3 
 4.2.5  Restricted colourants  
Dyed r eusabl e me nstrual cups  shall be free from listed restricted colourants, when tested in accordance with 
ISO 14632 -1, ISO 14632 -3, ISO  16373 -2 and ISO 16373 -3. 
Colourants on reusable me nstrual cups  shall be identified and classified in accordance with ISO 16373 -1  
5 Packaging  
Reusable menstrual  cups shall be individually wrappe d in suitable packaging to ensure that the hygienic 
quality and physical integrity of the product is  maintained . 
6 Labelling  
Each menstrual cup  pack shall be legibly and indellibly labelled with the following information:  
a) name  and address of the manufacturer ; 
b) produc t name, i. e. reusable menstrual cup ; 
c) volume of flow that can be collected;  
d) dimensions (i.e. cup length , stem length  (where applicable) , diameter  and wall thickness ); 
e) material  compos ition (i.e. rubber or medical grade silicone) ; 
f) Warning concerning the hazards of menstrually related Toxic Shoc k Syndrome (TS S) such as , 
“Menstrual cup  use is associated with the Toxic Shock Syndrome. The potentially fatal disease 
causes women to experience fever, shock, lo w blood pressure, skin rashes,  liver and kidney 
abnormalities ”; 
g) country of origin/manufactu re; 
h) care and use instructions , including the emphasis on the importan ce of  personal hygiene, particularly 
the washing of hands before and after inserting the menstr ual cup. (Pictorials are recommended) ; 
i) storage instructions ; 
j) guidance and recommendation s on selection of a suitable size for on e’s flow and the range of other 
available sizes  (see Annex A  for more understanding of the factors affecting selection of sizes ); 
k) instructions for IUD users  
l) date of manufacture   
m) Lot/batch  number  
7 Samplin g and criteria  for conformity  
Sampling shall be done in accordance with US ISO 2859 -1 
 DUS  2381 : 202 2 
4 © UNBS 2022 – All rights reserved  
 Annex A 
(informative)  
 
Reusable menstrual cup sizing guidelines and recommendations  
Regarding personal choice and needs in size or sizes of menstrual cups , there are no absolute rules or 
guidelines tha t will guarantee a perfect fit.  
The vagina does not c hange size from adolescence to adulthood. What we are born with, that is the length of 
the vagina does not change after maturity. Muscles may be firmer or looser depending on many factors  such 
as fitnes s level, time just after a vagi nal birth.  The best siz e determination is done by trial testing .  
Most menstrual cup brands come in two or three size ranges. These are 15ml and 25ml menstrual cup s based 
on volume. Some companies offer a 3 0ml volume for those with a very heavy flow.  Table A.1 des cribes the 
factors to be considered when determining a me nstrual cup size.  
Table 1 — Factors to be considered when determining a menstrual cup size  
Factor  Recommendation  
Age Small and medium sizes are recommended for young girls 
while large sizes are  recommended for adults.  
However, other factors sh ould be fact ored in such as 
fitness activity level since pelvic floor mu scles may weaken 
over time.  
Volume of menstrual flow A lighter flow — where the need to change a regular pad a 
couple of times a day — usually equates to a smaller 
menstrual cup.  
A heavy flow — where the need to change a high 
absorbency pad every 2 to 3 hours — is often more suited 
to larger cup sizes.  
Vaginal birth Many adolescents who have not experienced a vaginal 
birth use a 25ml cup while many who have use a 15ml cup . 
Pelvic floor muscles may weaken afte r a vaginal delivery, 
but this is not an absolute determinant . 
Cervix height/  length of vaginal canal a A higher sitting cervix may indicate the need for the cup 
with a longer dimension for  ease of removal, whereas 
conversely, a shorter vaginal canal i.e., Lower positioned 
cervix may require a menstrual cup with a shorter profile.  
 
 
Fitness status  This can influence the tightness of the pelvic floor muscles . 
Active individuals may find they are fine w ith a smaller 
volume menstrual cup but this should be factored in with 
individual level of menstrual flow. Whereas a menstrual cup 
that is too small may result in leaking, conversely, a larger 
cup m ay lead to mild cramping or feelings of slight 
discomfort.  
Cup length and diameter  Length and diameter of menstrual cups vary from 
manufacturer to manufacture.  If a cup’s length is too long, it 
may touch the cervix and the stem may be felt externally by 
vulva. Both occurrences will lead to discomfort as the 
menstrual cup should be positioned below the cervix , not in DUS  2381 : 202 2 
© UNBS 2022 – All rights reserved  5 
 contact with it.  
A user should not feel a menstrual cup when it is properly 
positioned in the vagina. To note, if a menstrual cup is 
slightly too long and the stem is p rotruding outside the 
body, the stem of most cups can be removed without 
affecting the overall functionality of the device.  
Regarding diameter, the width at the opening of the 
menstrual cup should be wide enough to securely fit and 
stay in place in the vag ina. If the diameter is too narrow, 
leaking may be experienced. If it is too wide, it may lead to 
discomfort and overstimulate the nearby urethra causing a 
sensation of needing to urinate.  
Softness/  firmness  Silicone menstrual cups come in a range of softnes s to 
firmness. If too soft, the cup may fail to open at insertion 
thus potentially lead to leaking and discomfort.  
Likewise, a cup that is too firm may be a best choice for the 
more athletic user but may add to the challenge of folding 
for easy insertion.  
Menstrual Cups made with TPE have a standard flexibility 
that again is in the medium range of firmn ess. 
a To determine lengt h of vaginal canal, that is, whether the cervix is sitting high or low, insert your longest finger into your 
vagina on or just before the first day of your period and feel for your cervix. It will be at the top of your vaginal canal and 
should feel similar  to the tip of your nose —a smooth raised part with a dimple in the middle. If your finger has to go all the 
way in before  you reach your cervix, you likely have a high cervix. But if you reach it at the first knuckle, it’s likely low. In 
between is averag e. 
 
 
 
 
 DUS  2381 : 202 2 
© UNBS 2022 – All rig hts res erved  7 
 Certification marking  
Products that conform to Uganda standards may be marked with Uganda National Bureau of Standards 
(UNBS ) Certi fication Mark shown in the figure below.  
The use of the UNBS C ertification Ma rk is governed by the Standards Act, and the Regulations made 
thereunder. This mark can be used only by those licensed under the certification mark scheme operated by 
the Uganda Natio nal Bureau of Standards and in conjunction with the releva nt Ug anda Stand ard. The 
presence of this mark on a product o r in relation to a product is an assurance that the goods comply with the 
requirements of that standard under a system of supe rvision , con trol and testing in accordance with the 
certification mark  sche me of the Uganda National Bureau of Standards. UNBS mar ked products are 
continually checked by UNBS for conformity to that standard.  
Further particulars of the terms and condit ions of lic ensin g may be obtained from the Director, Uganda 
National Burea u of Standards.   
 
 DUS 2381 : 202 2   
 
ICS 11.020 
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© UNBS 2022– All right s reserved